Home›Israel›Brainlab , Ltd.

Brainlab , Ltd.

Israel · Petach-Tikva

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 4 registration records and 142 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 17Class II 4

61 including historic records

SASaudi ArabiaSFDA

5registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

5device registrations

CLASS B 1CLASS C 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 3IIb 2Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class III 5

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States4 registration records, 142 510(k), 0 PMA, 4 excluded

Brazil21 confirmed, 1 excluded

Saudi Arabia5 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Brainlab Ltd. · BRAINLAB LTD. · BRAINLAB LTDA · BRAINLAB AG · Brainlab AG

Business registration

Legal name: BRAINLAB LTD
Company number: 513417121
Registration status: Active
Incorporated: 2003-06-02

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

62005

102006

72007

62008

42009

32010

62011

52012

12013

32014

12016

22017

12018

52019

72020

72021

72022

92023

42024

92025

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252476	Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout	2025-10-16
US	K252562	Spine & Trauma Navigation Instruments	2025-09-12
US	K243432	Vascular Navigation PAD 2.0; Navigation Software Vascular PAD	2025-07-22
BR	80042070042	Família de Capas Protetoras Descartáveis	Class I
BR	80042070007	ESFERAS MARCADORAS REFLEXIVAS DESCARTAVEIS PARA NAVEGACAO CIRURGICA	Class I
BR	80042070064	Buzz Virtual	Class I
SA	ME0000000965SFDAA00001	Quentry.com	—
SA	ME0000000965SFDAA00002	Quentry Mobile	—

Brainlab , Ltd.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies